Establishing Guidelines for Manual Lymphatic Drainage

NCT05509062 | Completed

• 1 other identifier: 22-0733
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to establish optimal guidelines for Manual Lymphatic Drainage in participants with lower extremity lymphedema.

Conditions

Lymphedema of Leg

Outcome Measures

Primary Outcomes (1)

• Change in The L-dex (Lymphedema Index).

  The L-DEX score represents the difference in the amount of extracellular fluid in an at-risk limb compared to an unaffected limb.

  18 months

Secondary Outcomes (8)

• Change in Total body weight in liters

  18 Months

• Change in Extracellular Fluid in liters

  18 months

• Change in Intracellular Fluid in liters

  18 Months

• Change in Skeletal Muscle Mass in lbs

  18 Months

• Change in Fat Mass in lbs

  18 Months

Study Arms (3)

Light Tactile Pressure

ACTIVE COMPARATOR

light tactile pressure with 5-10 mmHg without skin stretch

Procedure: Pressure

Medium Tactile Pressure

ACTIVE COMPARATOR

medium tactile pressure of 11-20 mmHg and medium skin stretch with therapist in a stationary position

Procedure: Pressure

Firm Tactile Pressure

ACTIVE COMPARATOR

firm tactile pressure (\> 21 mmHg) and maximal skin stretch with therapist weight shift

Procedure: Pressure

Interventions

Pressure PROCEDURE

Subjects are randomized to one of three treatment groups

Firm Tactile Pressure; Light Tactile Pressure; Medium Tactile Pressure

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adults between the age of 30 - 75 years
• Lower extremity lymphedema

You may not qualify if:

• Pregnant women
• Participants who are unable to stand independently for up to 2 mins
• Participants who cannot make their own decisions
• Participants undergoing cancer treatment
• Participants with an Infection (active cellulitis)
• Participants with a known Iodine Allergy
• Participants who weigh more than 375 lbs
• Participants with cardiac arrhythmias or implanted electronic equipment
• Participants who have undergone joint replacement in involved extremity
• Participants with cardiac insufficiency

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Interventions

Pressure

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Marco Del Chiaro

  University of Colorado Denver | Anschutz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment Group 1 Treatment Group 2 Treatment Group 3

Study Record Dates

• First Submitted: July 24, 2022
• First Posted: August 19, 2022
• Study Start: July 20, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)